(51 days)
Not Found
Yes
The device description explicitly lists "Zelda (AccuRhythm) AI ECG Classification System Models ZA400, ZA410, and ZA420" as a component of the LINQ II ICM.
No
The device is described as a monitoring system that records ECG and detects arrhythmias. Its primary function is diagnostic and monitoring, not therapeutic intervention.
Yes
Justification: The device records subcutaneous ECG and is indicated for patients with symptoms or conditions that suggest a cardiac arrhythmia, and it automatically detects and records occurrences of arrhythmias. This indicates its use in identifying and characterizing medical conditions.
No
The device description explicitly states that the LINQ II ICM is an "insertable programmable device" that "continuously monitors a patient's ECG and other physiological parameters." This indicates a physical, implantable hardware component, not a software-only device. While it includes software components like the MyCareLink Heart App and the Zelda AI system, the core medical device is the insertable monitor.
Based on the provided information, the LINQ II ICM is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes. This examination is performed outside of the living body (in vitro).
- LINQ II ICM Function: The LINQ II ICM is an insertable device that records subcutaneous ECG. This means it is placed inside the patient's body and directly monitors electrical activity of the heart. It does not analyze specimens taken from the body.
- Intended Use: The intended use describes monitoring for cardiac arrhythmias based on the recorded ECG signals, not analyzing biological samples.
While the device uses AI for ECG classification, and this classification contributes to the diagnostic process, the device itself is performing an in vivo measurement (within the body) rather than an in vitro analysis of a specimen.
No
The input letter does not contain any statement indicating that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The provided text explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found".
Intended Use / Indications for Use
The LINQ II ICM is an insertable automatically activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, in the following cases:
· Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
· Patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia
Product codes (comma separated list FDA assigned to the subject device)
MXD
Device Description
The LINO II Insertable Cardiac Monitor (ICM) Model LNQ22 is a programmable device that continuously monitors a patient's ECG and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings. The device is designed to automatically record the occurrence of an episode of arrhythmia in a patient. Note: Arrhythmias are classified as tachvarrhythmia. bradyarrhythmia, pause, atrial tachyarrhythmia, or atrial fibrillation. Patients may also manually record symptoms. In order to manually record symptoms, the patient will also need either the MyCareLink Heart App (patient app on mobile device) or the Patient Assistant Model PA97000. The patient can use the MyCareLink Heart App or the Patient to manually record his or her cardiac rhythm while experiencing or immediately after a symptomatic event. LINQ II ICM includes the following medical accessories: LINQ Tool Kit Model LNQ22TK, Patient Assistant Model PA97000, Reveal LINQ™ Mobile Manager Model MSW002 with patient connector Model 24967, Device Command Library Model 2692, Instrument Command Library Model 2691, and the Zelda (AccuRhythm) AI ECG Classification System Models ZA400, ZA410, and ZA420.
The LINO II ICM consists of a hybrid substrate that is made of sapphire. The sapphire provides part of the implantable hermetic enclosure, integrates the feedthroughs directly into the substrate, and provides a substrate for component attachment/interconnect. The antenna and sense electrodes are titanium foil laser bonded to the outside of the sapphire substrate and connected directly to the embedded feedthroughs. The sense electrodes are coated with sputtered titanium nitride. The sapphire is laser bonded to the titanium battery cover, which provides the complete hermetic enclosure. The battery is Lithium anode, silver vanadium oxide/carbon monofluoride cathode with a capacity of 167 mAh.
The LINO II ICM has a small form factor, and uses Sapphire. Titanium. Parylene, and Titanium Nitride coating on the sensing electrodes as body contacting materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Zelda (AccuRhythm) AI ECG Classification System Models ZA400, ZA410, and ZA420.
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous ECG
Indicated Patient Age Range
adult patients, and in pediatric patients who are at least 2 years old
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The design process for the proposed labeling updates involved requirements review, impact analyses, risk management activities, design verification, and clinical evaluation to demonstrate that the LINQ II ICM with the proposed labeling changes met design requirements, is safe and effective for use in the pediatric patient population, and is substantially equivalent to the predicate LINQ II ICM (K200795).
Design Verification: Electrical device verification testing was conducted for Low Field ● MRI test conditions and test protocols to ensure that the product operated as expected. The test executions resulted in a status of Pass and all test results and rationale demonstrate the final set of electrical requirements are met.
Design Validation: Updates to design input requirements were validated. Design ● validation acceptance criteria have been met, and the requirements meet the stakeholder needs.
Clinical Evaluation: A retrospective clinical evaluation of published literature, post-. market surveillance data, and studies was performed to assess the safety and effectiveness of the LINO II ICM existing indications for use in the pediatric patient population.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
LINQ II Insertable Cardiac Monitor, ModelLNQ22 (K200795)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo features the Department of Health & Human Services logo on the left. To the right of that is the FDA logo in blue, with the words "U.S. Food & Drug Administration" written in blue text.
August 25, 2022
Medtronic, Inc. Dianna Johannson Distinguished Regulatory Affairs Advisor 8200 Coral Sea Street NE Mounds View, Minnesota 55112
Re: K221962
Trade/Device Name: LINQ II Insertable Cardiac Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: MXD Dated: Julv 1. 2022 Received: July 5, 2022
Dear Dianna Johannson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hetal Odobasic Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221962
Device Name
LINQ II Insertable Cardiac Monitor (Model LNQ22)
Indications for Use (Describe)
The LINQ II ICM is an insertable automatically activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, in the following cases:
· Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
· Patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Restorative Use (Part 61 CFR 391 Subpart D) | On-The-Road Use (61 CFR 391 Subpart G) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Date Prepared: | July 1, 2022 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Cardiovascular Diagnostics and Services | |
| 8200 Coral Sea Street NE | |
| Mounds View, MN 55112 | |
| Establishment Registration Number: 2182208 | |
| Contact Person: | Dianna L Johannson |
| Distinguished Regulatory Affairs Advisor | |
| Cardiovascular Diagnostics and Services | |
| Phone: (763) 526-2376 | |
| Fax: (651) 367-0603 | |
| Email: dianna.johannson@medtronic.com | |
| Alternate Contact: | Ryan Calabrese |
| Sr Regulatory Affairs Director | |
| Cardiovascular Diagnostics and Services | |
| Phone: (763) 526-3515 | |
| Fax: (651) 367-0603 | |
| Email: ryan.s.calabrese@medtronic.com |
General Information
| Trade Name: | LINQTM II |
|---|---|
| Common Name: | Insertable Cardiac Monitor |
| Regulation Number: | CFR 870.1025 |
| Product Code: | MXD |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
| Special Controls: | Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm |
| Predicate Device: | LINQ II Insertable Cardiac Monitor, Model LNQ22 (K200795) |
4
Device Description
The LINO II Insertable Cardiac Monitor (ICM) Model LNQ22 is a programmable device that continuously monitors a patient's ECG and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings. The device is designed to automatically record the occurrence of an episode of arrhythmia in a patient. Note: Arrhythmias are classified as tachvarrhythmia. bradyarrhythmia, pause, atrial tachyarrhythmia, or atrial fibrillation. Patients may also manually record symptoms. In order to manually record symptoms, the patient will also need either the MyCareLink Heart App (patient app on mobile device) or the Patient Assistant Model PA97000. The patient can use the MyCareLink Heart App or the Patient to manually record his or her cardiac rhythm while experiencing or immediately after a symptomatic event. LINQ II ICM includes the following medical accessories: LINQ Tool Kit Model LNQ22TK, Patient Assistant Model PA97000, Reveal LINQ™ Mobile Manager Model MSW002 with patient connector Model 24967, Device Command Library Model 2692, Instrument Command Library Model 2691, and the Zelda (AccuRhythm) AI ECG Classification System Models ZA400, ZA410, and ZA420.
Indications for Use
The LINO II ICM Indications for Use statement is impacted as a result of this submission and is as follows:
The LINQ II ICM is an insertable automatically activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, in the following cases:
- . Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
- . Patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia
Technological Characteristics
The LINO II ICM consists of a hybrid substrate that is made of sapphire. The sapphire provides part of the implantable hermetic enclosure, integrates the feedthroughs directly into the substrate, and provides a substrate for component attachment/interconnect. The antenna and sense electrodes are titanium foil laser bonded to the outside of the sapphire substrate and connected directly to the embedded feedthroughs. The sense electrodes are coated with sputtered titanium nitride. The sapphire is laser bonded to the titanium battery cover, which provides the complete hermetic enclosure. The battery is Lithium anode, silver vanadium oxide/carbon monofluoride cathode with a capacity of 167 mAh.
The LINO II ICM has a small form factor, and uses Sapphire. Titanium. Parylene, and Titanium Nitride coating on the sensing electrodes as body contacting materials.
When compared to the predicate LINO II ICM (K200795), the LINO II ICM with the proposed labeling changes has the same operating principle, device technology and functionality, and safetv.
When compared to the predicate LINQ II ICM (K200795), the LINQ II ICM differs only in its updated labeling to extend the existing indications for use to the pediatric patient population, and
5
to expand the MRI conditions for use from a static magnetic field of 1.5 T or 3.0 T to static magnetic fields of